Lactosorb Push Screw
FDA 510(k) K002423 · Biomet, Inc.
510(k) numberK002423
Submission
- Device name
- Lactosorb Push Screw
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- August 8, 2000
- Decision date
- October 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Lactosorb Push Screw cleared by the FDA?
Lactosorb Push Screw (K002423) received a 510(k) decision of Substantially Equivalent on October 20, 2000, 73 days after the submission was received.
What is the product code of K002423?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.